Venous thromboembolism (VTE) is a common complication and a significant cause of mortality in hospitalized patients,characterized by high incidence,high mortality,and high medical burden.This expert consensus,based on the latest domestic and international evidence-based medical evidence and graded using the Grading of Recommendations,Assessment,Development,and Evaluation (GRADE) system,focuses on VTE prevention and control during the perioperative period.From a pharmacist's perspective,it systematically evaluates the rational use of anticoagulant drugs and the key points of pharmaceutical care across different departments and disease populations.Specific recommendations are provided for 16 clinical issues,including the establishment of a multi-disciplinary VTE management model during the perioperative period,the role and responsibilities of clinical pharmacists,commonly used anticoagulant drugs and their management in perioperative VTE prevention and control,and pharmaceutical care for special populations.The aim is to provide a reference for the standardized use of anticoagulants in perioperative VTE prevention and treatment in Chinese medical institutions,thereby improving healthcare quality and ensuring patient safety.
Objective To explore the effect and mechanism of Sechang Zhixie Powder (SCZXS) on mice with acute diarrhea caused by castor oil. Methods The mice were randomly divided into blank control group,model control group,montmorillonite powder group (1.4 g·kg-1),SCZXS-L group (0.9 g· kg-1),SCZXS-M group (1.8 g·kg-1) and SCZXS-H group (3.6 g·kg-1),10 mice in each group.After continuous administration of 7 days,the acute diarrhea model of mice was prepared by oral administration of castor oil (0.01 mL·g-1).The diarrhea of mice was observed within 4 hours of castor oil administration,and the rate of loose stool,degree of loose stool,and diarrhea index were calculated;the levels of DAO,D-LDH,VIP,and SS in the colon were determined by enzyme-linked immunosorbent assay;The morphological changes in the colon tissue of mice were observed after HE staining and the thicknesses of the mucosal and muscular layers of the colon were quantified;AB-PAS staining was performed to observe the effect on mucin in the colon;and the expression of AQP3,Occludin,and ZO-1 in the colon were quantified by immunohistochemistry. Results Compared with the model control group,the rate of loose stool,degree of loose stool,and diarrhea index of the mice in the SCZXS groups tended to decrease,but the difference was not statistically significant.Compared with the model control group,the flat luminal surface of the mice in the SCZXS-M and SCZXS-H group were significantly thickened (P<0.01),and the amount of VIP in the colon was significantly decreased (P<0.05,P<0.01),and that of DAO in the colon was significantly decreased (P<0.01),Occludin and ZO-1 expression were significantly increased (P<0.01),the mucin area ratio was significantly increased (P<0.05) in the SCZXS-M group,and AQP3 expression was significantly increased (P<0.05) in the SCZXS groups. Conclusions SCZXS can improve acute diarrhea induced by castor oil in mice.and its mechanism may be related to the regulation of gastrointestinal hormones and AQP3.In addition,SCZXS improves intestinal damage caused by diarrhea and protects the intestinal barrier.
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China. This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information, relevant domestic and international standards, the establishment of key quality attributes of metallic pharmaceutical packaging materials, and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines, the Pharmacopeia of the People's Republic of China 9625, prioritized product critical quality attributes(CQAs) and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
The 2025 Edition of the Pharmacopoeia of the People's Republic of China added the physical performance evaluation method of metallic metered dose inhalation (MDI) canister and related standards.The relevant physical performance evaluation methods are of great significance to the quality control of metallic inhalation canister,which is an important basis for the evaluation of drug protection ability,and also fills the blank of the physical performance evaluation method of metallic cans for drug packaging.It can scientifically and effectively guide the drug packaging material production enterprises to carry out standardized and unified quality control of metallic MDI inhalation canister,play a role in the quality control of metallic MDI inhalation canister,and ensure the safety,effectiveness, and accessibility of drugs in the whole life cycle.By comparing the domestic and international standards of metallic canister,this document mainly analyzed the detection principle,method points and its role in drug packaging quality control of pressure resistance performance、internal coating continuity, oxide film thickness, coating surface energy and coating contact angle,to help all parties more effectively and fully understand,master and apply the physical performance evaluation methods of the metallic MDI inhalation canister and relevant standards in the 2025 Edition of the Pharmacopoeia of the People's Republic of China,and provide theoretical guidance and technical support for the implementation of the standard.
To promote the understanding of the requirements for metal materials and containers used for drug packaging in the 2025 edition of the Pharmacopoeia of the People's Republic of China for related enterprises.Based on this edition of the Chinese Pharmacopoeia,national standards for drug packaging materials,and relevant international standards such as the United States Pharmacopoeia (USP). The raw material selection,production process, and quality control indicators of metal pharmaceutical packaging materials were systematically sorted out.It was necessary to clarify that for the metal material itself,the base material and coating type should be selected based on the characteristics of the medicine.In terms of the production process,attention should be paid to the impact of the forming process on the material performance.In terms of quality control,it is necessary to combine the material characteristics and the drug requirements,and ensure its protection,safety, and functionality through standardized testing methods.By strengthening the quality control of metal pharmaceutical packaging materials,product quality can be ensured, and the innovative development of the industry can be promoted.
Aluminum foil for pharmaceutical packaging is a material used for solid dosage forms.Guideline 9625 of the Pharmacopoeia of the People's Republic of China (2025 edition), built on the concepts of whole-process quality control and risk management,specifies the quality requirements for aluminum foil.This article analyzed and discussed the critical quality attributes and technical control points of aluminum foil by examining its fundamental characteristics,production processes,and relevant domestic and international standards.This article aimed to provide guidance for stakeholders in understanding and applying the guidelines, thereby enhancing pharmaceutical packaging quality and fostering standardization across the industry.
Objective To establish methods for determining the leaching amount of bisphenol A monomer in metal coatings as one of the guidelines on metal materials and containers for drug packaging in the 2025 edition of the Pharmacopoeia of the People's Republic of China. Methods The formulation process of the method for determining the leaching amount of bisphenol A monomer in metal coatings was explained.Through the verification of the two analysis methods,the scientific and rational aspects of the method were examined,and the determination results of the leaching amount of bisphenol A monomer by high performance liquid chromatography (HPLC) and high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) were compared. Results HPLC was suitable for the detection of general routine samples and can obtain experimental results more efficiently; HPLC-MS/MS has higher sensitivity and selectivity,and is more suitable for the detection of trace bisphenol A in samples with complex substrates. Conclusion Enterprises and scientific research institutions can choose their own determination methods and formulate reasonable limits according to the actual situation of products and the configuration needs of daily testing instruments.
This article focused on the revision and application of General Rule 0982 Determination of Particle Size and Size Distribution by Light Scattering Method in the Chinese Pharmacopoeia(2025 edition).By referencing domestic and international technical requirements and considering practical applications, the structure and content of this general rule were analyzed, and specific revisions were proposed.Key recommendations included adding sections on method validation and results reporting to the current general rule, incorporating the appendix content into the main text, and revising/supplementing the method name, introduction, instrument requirements, and determination procedures.The revised light scattering method would strengthen China's capacity for pharmaceutical quality control.
Objective To establish a laser diffraction method for determining globule size distribution in medium and long chain fat emulsion injection (C8~24Ve). Methods The Mastersizer 3000 laser particle size analyzer and Hydro EV wet sampling device were used,with water as the dispersion medium.Critical parameters, including refractive index, absorption coefficient, obscuration, measurement duration, stirring speed, and sonication parameters, were systematically optimized.Comparative evaluations were conducted across different computational models (Mie vs.Fraunhofer theories) and instrument platforms. Results The optimized optical parameters for particle size distribution analysis of medium and long chain fat emulsion injection (C8~24Ve) were determined as follows:absorption rate 0.001, refractive index 1.52, measurement duration 10 s, stirring speed 1 200 r·min-1, with no sonication applied.Under these conditions, the method demonstrated satisfactory precision, repeatability, and robustness. Conclusions This method demonstrates operational simplicity, high accuracy, and excellent reproducibility, making it suitable for particle size distribution analysis of medium and long chain fat emulsion injection (C8~24Ve).The established protocol provides a valuable reference for the development of particle size determination methods for emulsion formulations.
Objective To study the influence of laser diffraction ultrasound parameters on the determination of particle size and particle size distribution of budesonide suspension for inhalation,and explore the rationality of ultrasound parameter settings of the laser diffraction method. Methods The Mastersizer 3000 was set to measure the particle size and particle size distribution of budesonide suspension for inhalation from 6 companies at different ultrasonic times,and the FlowCam was used to test the samples simultaneously. Results The ultrasound parameters have a significant impact on the particle size and particle size distribution of budesonide suspension for inhalation in some companies,and the FlowCam test results show that particles in some samples exhibit aggregation,which can be dispersed by ultrasound and affect the results. Conclusion It is necessary to optimize the ultrasound parameters of laser diffraction to determine the particle size and particle size distribution of suspension for inhalation,and verify the rationality of the ultrasound parameter settings through microscopic techniques.
In 2024,the Japanese Circulation Society (JCS) and the Japanese Heart Rhythm Society (JHRS) jointly released the updated guidelines for the management of cardiac arrhythmias.The guideline provided updates on strategies for arrhythmias management,including device therapy,catheter ablation,pharmacological treatment and comprehensive management of atrial fibrillation (AF).This article focuses on the management of AF,including stroke risk assessment,oral anticoagulation therapy,high-risk patients management,comprehensive strategies,and lifestyle interventions.The guideline proposed a new stroke risk scoring tool,the HELT-E2S2 score,refined the management of anticoagulation therapy in special high-risk patients,and updated comprehensive management strategies and lifestyle interventions for AF.These updates aim to enhance the prognosis and quality of life for AF patients,and also provide valuable insights for the management optimization of AF patients in China.
In August 2024,the European Society of Cardiology Working Group on the management of Peripheral Artery and Aortic disease issued the "Guidelines for the management of peripheral and aortic arterial disease".The guideline stated that peripheral artery and aortic diseases were very common,significantly increasing cardiovascular disease morbidity and mortality in the general population,and their prevention and treatment strategies needed to be strengthened.This article interpreted the content of antithrombotic drug therapy in the guideline from the perspective of drug therapy,which could provide a reference for clinicians and pharmacists to formulate antithrombotic strategies.
Objective To investigate the current clinical practices regarding perioperative discontinuation,bridging,and resumption of antiplatelet therapy in coronary heart disease (CHD) patients undergoing elective non-cardiac surgery or procedures,aiming to optimize perioperative antithrombotic management strategies. Methods A retrospective study was conducted on CHD patients requiring long-term oral antiplatelet therapy after percutaneous coronary intervention (PCI) who underwent elective non-cardiac surgery or procedures at a tertiary hospital in Hubei Province from January 1 to June 30,2024.Data on perioperative discontinuation,bridging,and resumption of antithrombotic drugs,as well as in-hospital bleeding events,were analyzed. Results A total of 338 hospitalized patients were included,with males accounting for 79.88% and the majority aged over 60 years.High bleeding-risk procedures comprised 56.61% of cases.Among 171 patients on single antiplatelet therapy (SAPT) preoperatively,8.19% continued therapy without interruption.Of the 157 patients who discontinued SAPT,67.25% received bridging therapy with low molecular weight heparin (LMWH),and 4.68% with sulodexide.Among 167 patients on dual antiplatelet therapy (DAPT) preoperatively,17.37% (29 cases) continued DAPT,while 122 discontinued it,with 85 receiving LMWH bridging.Postoperatively,58.64% (173/295) had not resumed antiplatelet therapy by discharge.Three intraoperative and 17 postoperative bleeding events (predominantly minor) were recorded. Conclusions Current perioperative antithrombotic management strategies for patients on long-term antiplatelet therapy undergoing elective surgery lack standardization,both domestically and internationally.Practices at this institution regarding drug discontinuation,bridging,and resumption diverged from guideline recommendations.However,the low observed bleeding rate and insufficient evidence highlight the need for well-designed clinical studies to address unresolved issues in perioperative antithrombotic management.
Objective To evaluate the effect of clinical pharmacists in prescription intervention on rivaroxaban anticoagulation within non-valvular atrial fibrillation (NVAF) patients. Methods We collected 101 NVAF patients from January to June 2022 as the control group,and 125 NVAF patients from January to June 2023 after clinical pharmacists intervention as observation group.We audited the rivaroxaban prescriptions of the two groups of patients according to the evaluation criterion of appropriateness of rivaroxaban prescriptions for NVAF patients in our hospital.The rationality of rivaroxaban prescriptions,rivaroxaban anticoagulation-related thrombotic events,and bleeding events were compared between two groups. Results Clinical pharmacists provided 105 prescription interventions for observation group patients,of which 69 (65.7%) were adopted and implemented by doctors.The rational rate of rivaroxaban prescription in the observation group was significantly increased (85.7% vs.16.8%,P<0.05).There were no statistical differences between the observation group and the control group in thrombotic events and major bleeding events during hospitalization (P>0.05),with a significant difference in thrombotic events 6 months after discharged (0.8% vs. 7.9%,P<0.05). Conclusion The clinical pharmacist prescription intervention can improve the rational rate of rivaroxaban prescription and reduce the risk of thrombotic and bleeding events,which is an important measure to advance the safety and effectiveness of anticoagulant therapy.
Objective To investigate the appropriateness of rivaroxaban prescription in hospitalized patients with atrial fibrillation,in order to provide a reference for prescription quality improvement projects. Methods Electronic medical records of patients with atrial fibrillation using rivaroxaban from a tertiary hospital were retrospectively analyzed.The suitability of rivaroxaban prescription was evaluated according to its indications,contraindications,usage, and dosage.If the reduction does not meet the reduction standard,it is defined as "off-label low dose";If the reduction standard is met but not reduced,it is defined as "off-label high dose". Results In this study,4 211 patients with atrial fibrillation using rivaroxaban were included to evaluate the suitability of prescription,of which 61 patients (1.45%) had unsuitable indications and 358 patients (8.50%) had unsuitable combined use.The remaining 3 792 patients (mean age 61.6 years;male 68.75%) were evaluated for the dose suitability of rivaroxaban.Among them,18.57% prescriptions were evaluated as inappropriate dosage;16.27% were "off-label low dose" and 2.29% were "off-label high dose".The influencing factors of prescription dose suitability were analyzed,which showed that patients who were female,underweight,older,and with renal insufficiency were more likely to be prescribed an inappropriate dose (high or low,P<0.01). Conclusions The vast majority of the prescribed doses of rivaroxaban in the cohort of patients with atrial fibrillation in this study were appropriate.Given clinicians' concerns about the risk of bleeding,low-dose prescriptions were more common in females,underweight,older,and patients with renal insufficiency patients or those taking other bleeding-prone medications.The review and reminder of fine prescription can be completed by improving the setting conditions of the rational drug use software.
Objective To establish a molecular method for the identification of Aucklandia lappa Decne.and its common adulterants, Inula helenium L., based on tetra-primer amplification refractory mutation system (ARMS). Methods After the analysis and comparison of internal transcribed spacer 2 (ITS2)sequence differences between Aucklandia lappa Decne.and Inula helenium L.,single-nucleotide polymorphism (SNP) sites were found to design specific primers for identification,the ARMS method was established to specifically amplify samples from different sources,and identification was carried out according to the size of specific amplification bands. Results The results showed that 170 bp and 271 bp specific bands could be amplified by Aucklandia lappa Decne.and Inula helenium L.,respectively, under the following conditions: annealing temperature 56 ℃,cycle number 25,primer concentration ratio of internal and external primers 1:4,agarose gel concentration 1.5% and using 2×TSINGKE Master Mix (blue),the detection limit of adulterates in Aucklandia lappa Decne.and Inula helenium L.mixture sample was 5%.The 23 samples collected from the market were identified,results comparison was the same among ARMS detection,DNA barcoding, and plant classification. Conclusion The ARMS method established in this study can accurately identify Aucklandia lappa Decne. and Inula helenium L.,which has the characteristics of strong specificity and high sensitivity and simple operation,can provide basic research for solving the problem of admixture identification and technical support for the quality control of Aucklandia lappa Decne. medicinal materials.
Objective To investigate the nebulization characteristics of human interferon α1b for injection.To characterize and compare the delivery rate,total drug substance and the aerodynamic characteristics between the two types of nebulizer. Methods Connect two types of nebulizers with a breathing simulator,respectively, and simulate the breathing patterns of an infant and child.Measure the delivery rate,total delivered dose, and delivery uniformity.The aerodynamic properties of human interferon α1b for injection were evaluated by the next generation impactor (NGI).The content of human interferon α1b was quantified by double antibody sandwich ELISA. Results In the three batches of samples in infant mode,the delivery rate and total delivered dose determind by A nebulizer were 0.45,0.49,0.44 μg·min-1,3.06,3.21,3.81 μg,respectcively;and 0.12,0.14,0.16 μg·min-1,0.73,0.73,0.75 μg,respectcively by B nebulizer.In child mode,the delivery rate and total delivered doses determined by A nebulizer were 1.36,1.49,1.20 μg·min-1,7.44,7.17,and 6.54 μg,respectcively;and 0.37,0.36,0.43 μg·min-1,1.66,1.59,and 1.41 μg,respectcively by B nebulizer.In child and infant mode,the ten results of the total drug substance delivered determined by nebulizer A were both between 65% to 135% of the average.The FPD,FPF,MMAD, and GSD determined by A neublizer of three batch samples were 2.48,2.92,2.35 μg,59.0%,57.4%,59.1%,4.18,4.34,4.15 μm,1.94,1.98,2.01,respectively.The FPD,FPF,MMAD and GSD determined by B neublizer of three batches samples were 2.70,3.38,3.06 μg,67.6%,66.4%,66.3%,3.55,3.65,3.68 μm,2.03,2.04,2.06,respectively. Conclusions The data obtained in this research characterized the in vitro nebulization characteristics of human interferon α1b for injection and provided a theoretical basis and reference for in vitro study and clinical practice.The influence of different types of nebulizers on nebulization characteristics was evaluated as well.It is suggested that the quality standard of nebulizers be strictly formulated and the use of nebulizers be standardized.
Objective To investigate the occurrence of liver function abnormalities in patients with follicular lymphoma (FL) treated with the G-CDOP regimen in the real world. Methods Using the hospital information system,a retrospective collection of clinical data was conducted on inpatients diagnosed with FL and treated with at least four courses of the G-CDOP regimen in the Department of Hematology, the First Affiliated Hospital of Soochow University from September 2021 to August 2023.The analysis focused on the incidence,severity,and types of liver function abnormalities,as well as the timing of these occurrences in relation to medication use and other relevant clinical characteristics. Results The study encompassed a total of 55 patients with FL,out of which 30 patients encountered liver function abnormalities during the G-CDOP regimen treatment,yielding an incidence rate of 54.5%.There were 23 cases (41.8%) of grade 1,3 cases (5.5%) of grade 2,and 4 cases (7.3%) of grade 3 liver function abnormalities.Among them,12 cases (21.8%) were hepatocellular injury type,while the cholestasis type was observed in 4 cases (7.3%),and the mixed type was found in 14 cases (25.5%).Liver function abnormalities appeared in 21 patients (38.2%) during the first cycle of the G-CDOP regimen treatment,5 patients (9.1%) in the second cycle,and 1 patient (1.8%),2 patients (3.6%),and 1 patient (1.8%) in the third,fourth,and fifth cycles. Conclusion The G-CDOP regimen has the potential to impact liver function indicators in FL patients,but most are mild and reversible.However,there are also cases of severe liver injury that need to attract clinical attention.
Objective To conduct a comprehensive evaluation of Amphotericin B Deoxycholate (AmB-D) for injection,Liposomal Amphotericin B (L-AmB) for injection,and Amphotericin B Colloidal Dispersion (ABCD) for injection,and to provide a reference for the selection and rational use of drugs in medical institutions. Methods Based on the quantitative evaluation and selection record form in the A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition),evidence was collected to conduct a comprehensive assessment of the included drugs. Results Comprehensively considering the pharmacological properties,efficacy,safety,economy, and other attributes of different preparations of amphotericin B,the quantitative scoring results were ranked from high to low,with ABCD (CSPC Ouyi Pharmaceutical Co.,Ltd.) scoring 79.10 points,L-AmB (Gilead Sciences) scoring 78.30 points,and L-AmB (Shanghai Shangyao Xinya Pharmaceutical Co.,Ltd.) scoring 72.01 points.AmB-D (Shanghai Shanghai Pharmaceutical Xinya Pharmaceutical Co.,Ltd) scored 63.20 points,and AmB-D (North China Pharmaceutical Co.,Ltd.) scored 59.78 points. Conclusion Both L-AmB and ABCD have better clinical efficacy and higher safety in the treatment of invasive fungal infections,and ABCD has a better price advantage than L-AmB.Based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition), the evaluation results of different preparations of amphotericin B can provide a reference for the selection and rational use of amphotericin B in medical institutions.
Objective To explore the application of information technology in the management of the new outpatient Pharmacy of Beijing Chaoyang hospital,and to provide references for the construction or operational management of new hospital campuses in other institutions. Methods BI technology,Apriori algorithm,and activity based classification (ABC) method were utilized to optimize the allocation of personnel,drug storage locations,and cargo positions in the new outpatient dispensing center.The window prescription volume,number of dispensing positions,average dispensing time,and average patient waiting time were compared before and after the optimization. Results With the continuous increase in prescription volume at the new hospital campus,the average dispensing time and average patient waiting time decreased significantly from (143.80±15.62) s and (325.43±39.29) s to (100.26±17.85) s and (222.56±39.84) s,respectively (P<0.05). Conclusion Information pharmacists can optimize human resources and drug storage locations through BI technology,Apriori algorithm,and ABC method,providing valuable references for the management of outpatient dispensing centers in newly opened hospital campuses.
Objective To evaluate the practical application of the Media Fill Test (MFT) in assessing aseptic compounding competency of personnel in Pharmacy Intravenous Admixture Services (PIVAS). Methods A multicenter controlled study was conducted across six tertiary hospitals (center ①-⑥) in China.Participants were divided into an inexperienced group (Group A,n=118) and an experienced group (Group B,n=118),each performing five MFT operations.Positive controls validated medium efficacy.Contamination rates and pass rates were analyzed using chi-square and Fisher’s exact tests. Results Valid samples included 584 for Group A and 588 for Group B.The sample pass rate was 66.78% (390/584) in Group A and 91.67% (539/588) in Group B,while personnel pass rates were 46.15% (54/117) and 80.51% (95/118),respectively,with significant intergroup differences (both P<0.01).All centers except Center ⑥ showed significantly higher pass rates in Group B (all P<0.05). Conclusion MFT effectively differentiates technical proficiency levels and is suitable for training evaluation of novice PIVAS staff.
Objective This study comprehensively analyzes the current implementation status and influencing factors of the "Administrative Measures for Surplus Drugs of Medical Institutions (Trial)" (referred to as the "Measures"),it helps solve the problems that have long plagued the management of surplus drugs in medical institutions. Methods Based on the framework of Health Policies Triangle,starting from the policy content,and from the perspectives of various actors,a questionnaire was designed from three dimensions: the current implementation status,the implementation effect,and the countermeasures suggestions. The management of surplus drugs in secondary and tertiary medical institutions throughout the province was investigated,then we will analyze the investigation results,evaluate the implementation effectiveness and influencing factors,and propose targeted suggestions. Results 84% of medical institutions have fully or partially implemented the measure,The implementation of the "Measures" has prevented hospitals from being subject to administrative penalties again due to surplus drugs,determined the disposal methods for surplus drugs,promoted the establishment of surplus drug management systems and directories by implementing hospitals,and clarified the varieties of surplus drugs in Shanxi Province. Conclusion The "Method" has significant implementation effects and clarified management provisions and filled the gaps in current management.The problems encountered include: The definition of surplus medicines limits the implementation of the "Measures" in secondary hospitals;The measures to reduce surplus drugs at the source have not been detailed;the awareness of the content of the "Measures" is insufficient; the collaboration among departments is lacking. It is suggested to revise and implement the "Measures" by clarifying the categories of drugs that can be charged by the unit and management rules in Shanxi Province,optimizing the definition of surplus drugs,clarifying the management regulations of each department,refining the informed consent method of patients,expanding the scope of special funds. In addition,the publicity efforts for "Measures" need to be strengthen,in order to further solve the problem of surplus drug management in medical institutions.
Objective To explore the impact of factors such as economic level,regional differences,and healthcare policies on the medical costs and the clinical treatment behaviors for benign prostatic hyperplasia (BPH) using big data technology. Methods A combination of qualitative and quantitative approaches was employed,including descriptive statistical analysis,central tendency analysis,comparative analysis,and structural analysis to explore regional differences in the treatment of BPH and the underlying causes. Results The mean medical cost per case in the provincial capital city (19 502 yuan) was significantly higher than that in the prefecture-level city (16 526 yuan), with a difference of 2 976 yuan (+18%).Moreover, the cost distribution was more dispersed in the provincial capital ([8 370 yuan-26 344 yuan] vs.[9 687 yuan-21 974 yuan] in the prefecture-level city).However, the provincial capital demonstrated better hospitalization efficiency, with a significantly shorter mean length of stay (9.24 days vs 10.21 days, -10.5%).All these differences were statistically significant (P<0.01).Payment methods influenced surgical choices.In the provincial capital, 43.99% of patients underwent transurethral resection of the prostate (TURP), with no cases of holmium laser enucleation of the prostate (HOLEP).In contrast, the prefecture-level city reported 22.71% of patients receiving plasmakinetic resection of the prostate (PKRP) and 19.19% undergoing HoLEP.Significant differences were observed in antibiotic utilization patterns.The most commonly used antibiotic in the provincial capital was piperacillin-tazobactam (19.96%), while cefotaxime dominated in the prefecture-level city (21.11%).Notably, ertapenem was frequently used in the provincial capital but rarely in the prefecture-level city, potentially due to cost considerations (P<0.05).Regional preferences were evident in antispasmodic medication; phloroglucinol injection was used in 80% of cases in the prefecture-level city, while anisodamine hydrobromide injection predominated in the provincial capital (P<0.05).For BPH-specific medications, although tamsulosin hydrochloride sustained-release capsules were the primary choice in both regions, the prefecture-level city showed significantly higher usage (80.11% vs 49.17%).Finasteride tablets were more commonly prescribed in the provincial capital (39.03% vs.14.14%, P<0.05). Conclusion Economic levels,healthcare policies,and different hospitals significantly influence clinical decision-making and medical expenses.Hospitals should enhance refined management,while healthcare policy reforms need to advance from multiple perspectives and levels to improve the efficiency and equity of healthcare services.
Objective To analyze the procurement data of lipid-lowering drugs in hospitals at different levels in Jiangsu Province from October 2019 to September 2023,to evaluate the impact of the volume-based procurement (VBP) policy,and to provide references for clinical rational drug use and healthcare policy optimization. Methods Based on procurement data from the Jiangsu Provincial Health Information Center,statistical analyses of procurement expenditures,defined daily doses (DDDs),and defined daily cost (DDC) were conducted.Mixed-effects models were applied to assess changes in procurement expenditures,DDDs,and DDC before and after VBP implementation. Results From 2019 to 2023,statins dominated the market in Jiangsu Province,with rosuvastatin recording the highest DDDs (748 million).Statins,traditional Chinese medicines,and cholesterol absorption inhibitors ranked highest in procurement expenditures.Tertiary hospitals accounted for the largest share of usage (47.6%) and expenditures (55.8%),while secondary hospitals had the lowest DDC (1.22 yuan) and tertiary hospitals the highest (1.89 yuan).Post-VBP,procurement expenditures and DDC decreased by 53.9% and 35.4%,respectively.Primary hospitals showed the largest expenditure reduction (61.6%),and secondary hospitals exhibited the greatest DDC decline (53.9%).DDDs increased significantly in primary care settings (e.g.,pitavastatin surged by 239.79% in secondary hospitals),while tertiary hospitals saw reduced usage of some drugs (e.g.,amlodipine/atorvastatin decreased by 7.34%).Mixed-effects models confirmed that VBP significantly reduced expenditures (OR=-1.07,P<0.01) and DDC (OR=-2.70,P<0.01) while indirectly lowering prices of non-VBP drugs.After covariate adjustment,expenditure reductions for rosuvastatin and atorvastatin narrowed,ezetimibe expenditures increased (OR=0.13,P<0.01),and pitavastatin usage declined (OR=-0.10,P<0.01).Changes in amlodipine/atorvastatin and ezetimibe lacked statistical significance due to short VBP implementation periods.Tertiary hospitals demonstrated the strictest policy adherence,with the largest expenditure and DDC reductions (P<0.01).Subgroup analysis revealed that the policy did not significantly affect clinical demand (DDDs) in hospitals at different levels,though it was considered to have triggered adjustments in medication structure. Conclusion Jiangsu's lipid-lowering drug structure aligns with guidelines (statin-based,moderate-intensity preference).VBP effectively reduced costs,with tertiary hospitals prioritizing originator-to-generic substitution and primary hospitals reflecting cost-control and demand variations.Confounding factors influenced policy evaluation.The study recommends continuous monitoring and policy optimization to enhance procurement efficiency,ensure rational clinical use,and sustain cost savings,providing insights for further healthcare reform.